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NCT01872871 Clinical Trial

The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial

Retinopathy of Prematurity Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01872871
Other study ID # B.10.4.ISM.4.06.68.49/231
Secondary ID B.10.4.ISM.4.06.
Status Unknown status
Phase N/A
First received June 4, 2013
Last updated June 6, 2013
Start date January 2013
Est. completion date January 2014

Study information
Verified date June 2013
Source Dr. Sami Ulus Children's Hospital
Contact Serdar Beken
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.

Recruitment information / eligibility
Status Unknown status
Enrollment 80
Est. completion date January 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- gestational age below 32 weeks or birth weight below 1500 grams

Exclusion Criteria:

- congenital anomalies, necrotising enterocolitis, surgical problems

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Paracetamol
paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops
• Topical anaesthetic drop with placebo

Locations
Country Name City State
Turkey Dr. Sami Ulus Childrens Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Dr. Sami Ulus Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Allegaert K, Tibboel D, Naulaers G, Tison D, De Jonge A, Van Dijk M, Vanhole C, Devlieger H. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003 Jun;59(2):87-90. Epub 2003 Apr 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Reducing pain assessment score 2 weeks
See also
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